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Abstract
Systems and methods provide interface to a patient's autonomic nerves via an interior lumen wall of a blood vessel. Systems can include a probe having at least one electrode for receiving electrical signals from the interior of the lumen wall. The system can include processing components for extracting the signals from noise within the patient's body. Systems can include stimulation electrodes for providing stimulation and eliciting action potentials within the patient and destructive processes for destroying nervous function. The effect of nerve destruction on the propagation of action potentials can be effectively used as a feedback mechanism for determining the amount of nervous function destruction in the patient.
Core Innovation
A blood-vessel-insertable nerve probe and electronic control unit are used for real-time autonomic nerve assessment and feedback during nerve ablation. The probe includes a plurality of electrodes disposed on a portion sized and shaped to be inserted into a blood vessel proximate to nerve fibers, with an electrical control unit in electronic communication with the probe. Stimulation pulses applied via a stimulation set of electrodes stimulate nerve fibers to cause an elicited response that propagates in first and second directions generally opposite one another along the nerve fibers.
The probe also includes a recording set of electrodes configured to detect the elicited response propagating in the first direction from a first portion of the blood vessel toward a second portion of the blood vessel. Signal processing is used to extract neural activity from intra-body noise, including filtering, high-impedance recording circuitry, common-mode rejection, blanking, temporal windows, and signal averaging. Blocking pulses are delivered via a blocking set of electrodes to apply blocking pulses to a third portion of the blood vessel to prevent at least a portion of the elicited response from propagating in the second direction.
The described approach further supports feedback during destructive nerve ablation by comparing elicited potential amplitude before versus after ablation as an estimate of lesion completeness, including repeating stimulation and recording until suppression or elimination of the elicited response is indicated. A diagnostic process is also described for measuring baseline or spontaneous nerve activity proximate a vessel, such as the renal artery, to inform whether ablation is likely effective.
Claims Coverage
The partial content includes two independent claims. The inventive features focus on a vessel-insertable probe with separate stimulation, recording, and blocking electrode sets and opposite-direction propagation control and detection, and a method mirroring that apparatus arrangement while providing the blocking function and detection. Additional dependent-claim refinements describe organ-specific anatomy, timing relationships between blocking and stimulation, bipolar stimulation constraints, iteration/averaging for temporal-noise reduction, probe/electrode positional adjustment, and automatic bandwidth/resonant-frequency adjustment based on probe type.
Blood-vessel insertable probe with separate stimulation, recording, and blocking sets for opposite-direction propagation
A probe portion sized and shaped to be inserted into a blood vessel proximate to nerve fibers includes separate and spaced-apart stimulation set, recording set, and blocking set of electrodes; stimulation pulses applied to the stimulation set elicit a response propagating in first and second generally opposite directions along the nerve fibers, recording electrodes detect propagation in the first direction from a first vessel portion toward a second vessel portion, and blocking electrodes apply blocking pulses to a third vessel portion to prevent at least a portion of the elicited response from propagating in the second direction.
Method of stimulation, opposite-direction detection, and blocking using spaced electrode sets in a blood vessel
A method includes inserting a probe portion with a plurality of electrodes into a blood vessel proximate to nerve fibers, delivering stimulation pulses to a stimulation set to stimulate nerve fibers to cause an elicited response propagating in first and second generally opposite directions, detecting the elicited response with a recording set as propagating in the first direction from a first vessel portion toward a second vessel portion, and delivering blocking pulses to a blocking set to prevent at least a portion of the elicited response from propagating in the second direction from the first vessel portion toward the third vessel portion, wherein each of the stimulation set, the recording set, and the blocking set is separate from and spaced apart from the other sets.
Across both independent claims, the core claim coverage is the use of a blood-vessel-proximate electrode probe with distinct, spaced stimulation, recording, and blocking electrode sets that elicit an opposite-direction propagating nerve response, detect propagation in one direction, and apply blocking pulses to prevent propagation in the opposite direction. Dependent refinements described in the provided claim summaries include renal artery/renal nerves specificity, blocking during stimulation, bipolar stimulation, multiple-iteration averaging to reduce temporal noise, and automatic adjustment of bandwidth and resonant frequency based on probe type.
Stated Advantages
Provides real-time assessment and feedback during nerve ablation by using changes in elicited potential amplitude before versus after ablation to estimate lesion completeness.
Reduces temporal noise by delivering stimulation pulses in multiple separate iterations and averaging corresponding detected response signals.
Prevents at least a portion of the elicited response from propagating in the second direction by applying blocking pulses to a third vessel portion.
Improves stimulation of nerve fibers and/or detection of the elicited response by automatically adjusting component characteristics such as bandwidth and resonant frequency based on probe type.
Documented Applications
Real-time autonomic nerve assessment and feedback during a destructive nerve ablation process.
Diagnostic measurement of baseline or spontaneous nerve activity proximate a vessel, including an example using the renal artery, to inform whether ablation is likely effective.
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